LEXAPRO SUMMARY
LEXAPRO® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram.
LEXAPRO (escitalopram) is indicated for the following:
MAJOR DEPRESSIVE DISORDER
LEXAPRO (escitalopram) is indicated for the treatment of major depressive disorder.
The efficacy of LEXAPRO in the treatment of major depressive disorder was established in three, 8-week, placebo-controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The efficacy of LEXAPRO in hospitalized patients with major depressive disorders has not been adequately studied.
The efficacy of LEXAPRO in maintaining a response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking LEXAPRO and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use LEXAPRO for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
GENERALIZED ANXIETY DISORDER
LEXAPRO is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of LEXAPRO was established in three, 8-week, placebo-controlled trials in patients with GAD (see CLINICAL PHARMACOLOGY).
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
The efficacy of LEXAPRO in the long-term treatment of GAD, that is, for more than 8 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use LEXAPRO for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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LEXAPRO NEWS HIGHLIGHTS Media Articles Related to Lexapro (Escitalopram)
Lexapro Approved for Adolescent Depression
Source: MedicineNet escitalopram Specialty [2009.03.23]
Title: Lexapro Approved for Adolescent Depression
Category: Health News
Created: 3/21/2009 2:00:00 AM
Last Editorial Review: 3/23/2009
Zoloft, Lexapro the Best of Newer Antidepressants
Source: MedicineNet bupropion Specialty [2009.01.30]
Title: Zoloft, Lexapro the Best of Newer Antidepressants
Category: Health News
Created: 1/30/2009 2:00:00 AM
Last Editorial Review: 1/30/2009
Published Studies Related to Lexapro (Escitalopram)
Escitalopram for older adults with generalized anxiety disorder: a randomized controlled trial. [2009.01.21]
CONTEXT: Generalized anxiety disorder (GAD) is one of the most common psychiatric disorders in older adults; however, few data exist to guide clinicians in efficacious and safe treatment. Selective serotonin reuptake inhibitors (SSRIs) are efficacious for younger adults with GAD, but benefits and risks may be different in older adults. OBJECTIVE: To examine the efficacy, safety, and tolerability of the SSRI escitalopram [generic for Lexapro] in older adults with GAD... CONCLUSIONS: Older adults with GAD randomized to escitalopram had a higher cumulative response rate for improvement vs placebo over 12 weeks; however, response rates were not significantly different using an intention-to-treat analysis. Further study is required to assess efficacy and safety over longer treatment durations. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00105586.
No effect of six weeks of treatment with escitalopram on mood in healthy volunteers--irrespective of genotype for the promoter of the serotonin transporter. [2008.12.15]
Data on emotional effects of chronic antidepressants in normal subjects are scarce and contradictory. Thirty healthy men were given 10 mg/day of escitalopram [generic for Lexapro] for 6 weeks in a double-blind, placebo-controlled, within-subject cross-over study.No significant effect on negative affect, positive affect, or state anxiety was detected, irrespective of serotonin transporter gene-linked polymorphism.
Kinetics of omeprazole and escitalopram in relation to the CYP2C19*17 allele in healthy subjects. [2008.12]
PURPOSE: Ultrarapid drug metabolism of antidepressants has been associated with therapeutic failures. The CYP2C19*17 allele has been associated with higher levels of CYP2C19 gene transcription and increased rates of omeprazole and mephenytoin metabolism. The aim of this study was to compare the impact of the CYP2C19*17 allele on omeprazole single-dose kinetics with escitalopram [generic for Lexapro] exposure at steady state in volunteers genotyped as either CYP2C19*17/*17 or CYP2C19*1/*1... CONCLUSION: Based on our investigation using two different CYP2C19 substrates, we concluded that a clinically significant difference in escitalopram or omeprazole kinetics between the genotypes appears unlikely.
Escitalopram in painful polyneuropathy: a randomized, placebo-controlled, cross-over trial. [2008.10.15]
Serotonin (5-HT) is involved in pain modulation via descending pathways in the central nervous system. The aim of this study was to test if escitalopram [generic for Lexapro], a selective serotonin reuptake inhibitor (SSRI), would relieve pain in polyneuropathy...
Treatment of alcohol dependence in patients with co-morbid major depressive disorder--predictors for the outcomes with memantine and escitalopram medication. [2008.10.03]
BACKGROUND: Alcohol dependence comorbid with major depressive disorder poses a major challenge in the clinical setting. The results in the treatment with selective serotonin re-uptake inhibitors have been conflicting. Thus, we compared in alcohol-dependent patients with co-morbid major depressive disorder the selective serotonin re-uptake inhibitor escitalopram [generic for Lexapro] to a compound that acts on different transporter system and may reduce craving, the glutamate receptor antagonist memantine... CONCLUSION: Our results indicate that both memantine and escitalopram are useful adjunct medications for the treatment of alcohol dependence co-morbid with major depression. Memantine was at least as effective with regard to drinking as escitalopram. We believe that a direct comparison of memantine, with the commonly used escitalopram, can provide useful information for clinicians on the treatment of alcohol dependency co-morbid with MDD.
Clinical Trials Related to Lexapro (Escitalopram)
Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features [Completed]
Aims of Study:
The aims of this study are 1) to examine the clinical utility of escitalopram in patients
with major depression with atypical features; 2) to evaluate the tolerability of escitalopram
in major depression with atypical features.
Study hypothesis and objectives. This study is proposed as an open-label study to gather
pilot data to examine whether escitalopram has clinical utility in the treatment of major
depression with atypical features. Because of the exploratory nature of the design, no
specific study hypotheses can be generated regarding efficacy of the drug. Our primary
hypothesis is that the effect size of escitalopram in atypical depression will be similar to
the effect size of escitalopram in major depression, its FDA approved indication.
Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram
oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x
20 mg) dose administered under fed conditions.
Fasting Study of Escitalopram Oxalate Tablets 20 mg and Lexapro® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram
oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x
20 mg) dose administered under fasting conditions.
Efficacy of Escitalopram in the Treatment of Internet Addiction [Completed]
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and
effective in treating problematic internet use.
Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-Life Depression [Active, not recruiting]
This study will determine whether adding interpersonal psychotherapy to treatment with the
antidepressant escitalopram will be more effective in reducing symptoms of depression than
antidepressant medication alone.
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LEXAPRO PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 53 ratings/reviews, Lexapro has an overall score of 7.06. The effectiveness score is 7.81 and the side effect score is 7.47. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Lexapro review by 20 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | anxiety/depression |
| Dosage & duration: | | 10 milligrams (dosage frequency: daily) for the period of 7 months |
| Other conditions: | | endometriosis |
| Other drugs taken: | | Yasmin | | |
Reported Results |
| Benefits: | | Decreased depression. Decreased anxiety with heart palpatations. |
| Side effects: | | Decreased libido (which was temporary) |
| Comments: | | After about a week of taking the medication, I felt "like myself" again and not like a crazy person. I had felt that depression and anxiety were takin gover my personality. The medication neutralized these feelings. |
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| | Lexapro review by 56 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 20 mg taken once per day for the period of one and a half years |
| Other conditions: | | anxiety |
| Other drugs taken: | | hormone replacement | | |
Reported Results |
| Benefits: | | This drug was most effective in 'cooling' my anxiety. The depression was less affected, but definately improved. I felt much calmer and able to deal with my situation more effectively. I wasn't panic striken anymore or weeping all the time. |
| Side effects: | | At first the dose of 20mg left me a little zombie like. I'd sit and stare out the window all day. When the dose was reduced to 10mg. this side effect went away. I also developed a clenched jaw, which sometimes I snapped and my teeth grinding became much worse. I also developed ringing in my ears. I also gained weight, a total of 25 pounds. |
| Comments: | | I was treated for anxiety and depression with this drug, beginning with 20mg and then reducing it to 10mg. I was going through a divorse at the time and could not cope with the overwhelming crisis. This drug was given in combination with cognitive psychotherapy and together I believe they were very effective. I was able to be weaned off very easily after one and a half years and feel fine now. The side affects were a bit troublesome and they remain; ie. the teeth grinding and ringing in the ears and weight gain. |
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| | Lexapro review by 61 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | clinical depression |
| Dosage & duration: | | 10mg taken once a day for the period of 2 months |
| Other conditions: | | excessive anxiety/panic attacks |
| Other drugs taken: | | Glucovance for diabetes | | |
Reported Results |
| Benefits: | | The treatment benefits were very minimal because of the severe rage that I experienced. I don't think I benefited at all from taking this drug. |
| Side effects: | | This drug was very toxic to my system because it caused severe rage. I really was never relieved from my clinical depression because I kept hoping that the drug benefits would kick in and kept on taking it until one day I realized that I had to stop taking it. After about 2 months, I realized that I was very agitated constantly. I just thought that it would eventually go away but it never did. My nervousness was getting extreme. One day, I was in a grocery store shopping, pushing a grocery cart, and a little boy walked in front of me pushing a toy cart. I was so agitated that I had an INTENSE DESIRE to ram him with my shopping cart. I realized that this behavior was NOT ME and that the Lexapro was causing the severe rage. I also had a constant desire to start running down the street as fast as I could and NOT stop. I also couldn't sleep at night and if I was able to go to sleep finally, I would only stay asleep for a few hours. I sure hope this medication is taken off the market because it could cause some unstable patients to take other's lives from the severe rage. |
| Comments: | | This medication is manufactured by Forest Pharmaceuticals, Inc., a subsidiary of Forest Laboratories, Inc. in St. Louis Missouri 63045. I was given the prescription of taking 10 mg. once a day. I cannot even imagine what would have happened to me if I had taken the full dosage recommended of 20 mg. I would have probably hurt someone badly. I have always suffered from clinical depression and have taken many different medications. Right now, Paxil is helping me with my depression a little. I think that I need to have it "upped" because the usual dosage isn't as effective as it once was. Anyway, my psychiatrist prescribed Lexapro for me because he really believed that this new drug would be just perfect for me. I had no idea that it would cause such turmoil in my life. I was in a constant state of nervousness and my panic attacks had started to get much worse. I just thought that my daily routine was the cause for my anxiety but realized when I had the desire to shove my shopping cart into a little boy who walked in front of me in the store, as I stated before in this report, that I had to quit taking Lexapro. Sometimes, I would sit on my sofa at night and want so badly to just scream at the top of my lungs. My therapist just told me to take a pillow, put it over my face, and scream at the top of my lungs. I was afraid that my neighbors would call the police if they heard me. That was no way to live. This medication was so toxic to me that if I had not realized what it was doing to me, I might have even taken my own life. Because of my great faith in God, I didn't kill myself and finally realized that I had to call my doctor immediately the next morning to report what Lexapro was doing to me. I also have a friend who is taking Lexapro and has taken it for sometime. She also shows signs of rage at times. Just a minor infringement on her and she will go into a state of rage (but not as bad as I did). I have tried to tell her that she needs to get off Lexapro but she just thinks that OTHER people are intimidating her. One day, when she rams her car into someone elses because they pulled in front of her, she will finally realize that Lexapro is not the drug for HER either. I really do think that Lexapro should be taken off the market until further testing is done. I would NEVER recommend this drug to anyone. It is just too unstable. |
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Page last updated: 2009-03-23
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